Wednesday, August 15, 2018

Warning Letter of the Week: insanitary conditions edition

(From the inbox): Via a missive from the Director of Division of Pharmaceutical Quality Operations IV to the owner of BioDiagnostic International, some alarming comments:
Insanitary Conditions Violations
You manufacture [redacted], a drug product intended for vaginal use as a hemostatic solution to stop bleeding after cervical biopsies. During the inspection, our investigator observed filthy conditions in your facility, including dirty equipment and utensils covered with unknown residue. A large metal roll-up door at the entrance to your facility was open to the outdoors, while an open pot you use as a mixing vessel contained in-process material and was not covered. The insanitary conditions observed at your facility failed to protect drug products from contamination with filth.

CGMP Violations 
1.    Your firm failed to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).

Our investigator documented that you have an employee food preparation area within your drug manufacturing area with no separation between open manufacturing equipment, cooking utensils, and personal-use items. The practices observed at your facility, which was observed open to the outdoors, increase the likelihood of your drug products becoming contaminated.
Cooking utensils? That sounds... yucky.  

1 comment:

  1. I remember running across a story somewhere online about a company doing some kind of silicon wafer work under cleanroom conditions. Once in a while, everything they tried to make was ruined by organic contamination, and they could never figure out where it was coming from. One night, a scientist working late witnessed the cleaning staff heating up frozen pizza in a lab oven!


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